parallel randomized trial
NCT00701935
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Exenatide 10 ug subcutaneous twice daily Exenatide BID | metformin; lifestyle: not reported | 43 | 29 | |
| A2 | Placebo Placebo | metformin; lifestyle: not reported | 37 | 27 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Exenatide 10 ug subcutaneous twice daily A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 58.2 | 57.9 |
| age | sd (years) | 12.2 | 11.0 |
| female | n | 20 | 18 |
Analyses this trial contributes to
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Body weight change in kilograms (diabetes)Type 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- HbA1c below 7 percentType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Systolic blood pressure changeType 2 diabetes (adults); weeks 20 to 36 (target week 26); network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- NauseaType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- VomitingType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaType 2 diabetes (adults); longest follow-up; network meta-analysis
Results
20 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | change | -0.69 percent | 0.12 | 42 | not stated; modified itt; registry:outcomes | |
| 26.07 | A1 vs A2 | md | -0.88 percent | -1.19 to -0.57 | not stated; modified itt; registry:outcomes | ||
| 26.07 | A2 | change | 0.19 percent | 0.15 | 33 | not stated; modified itt; registry:outcomes |
Body weight change in kilograms (diabetes) (3 lines; O02)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | change | -2.54 kg | 0.57 | 42 | not stated; modified itt; registry:outcomes | |
| 26.07 | A1 vs A2 | md | -2.21 kg | -3.66 to -0.76 | not stated; modified itt; registry:outcomes | ||
| 26.07 | A2 | change | -0.33 kg | 0.72 | 33 | not stated; modified itt; registry:outcomes |
HbA1c below 7 percent (2 lines; O03)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | responders | 60.7 | 28 | not stated; completers; registry:outcomes | ||
| 26.07 | A2 | responders | 21.4 | 28 | not stated; completers; registry:outcomes |
Systolic blood pressure change (2 lines; O05)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 26.07 | A1 | change | -7.48 mmHg | 12.57 | 29 | not stated; modified itt; registry:outcomes | |
| 26.07 | A2 | change | 1.79 mmHg | 12.41 | 28 | not stated; modified itt; registry:outcomes |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 3 / 43 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 37 | not stated; safety; registry:adverse_events |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 15 / 43 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 11 / 37 | not stated; safety; registry:adverse_events |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 43 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 3 / 37 | not stated; safety; registry:adverse_events |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7 / 43 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 1 / 37 | not stated; safety; registry:adverse_events |
Intestinal obstruction or ileus (2 lines; O37B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 43 | not stated; safety; intestinal obstruction; registry:adverse_events | ||||
| A2 | events | 0 / 37 | not stated; safety; intestinal obstruction; registry:adverse_events |